KDC/ONE SOCAL LABORATORIES, LLC
Form 483 issued September 13, 2022 · Walnut, California
- Inspection
- Sep 7 – Sep 13, 2022
- Investigator
- Lisa Shin
- Observations
- 4
- Pages
- 5
- FEI number
- 3021082665
In short: On September 13, 2022, FDA issued a Form 483 with 4 observations to KDC/ONE SOCAL LABORATORIES, LLC in Walnut, California (FEI 3021082665) after an inspection that ran Sep 7 – Sep 13, 2022. The investigator was Lisa Shin. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Procedures describing the handling of written and oral complaints related to drug products are not written…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Records are not kept for…
This inspection in context
Lisa Shin
13 documents · 2020–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmKDC/ONE SOCAL LABORATORIES, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KDC/ONE SOCAL LABORATORIES, LLC?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected KDC/ONE SOCAL LABORATORIES, LLC?
Lisa Shin is named on this Form 483, for the inspection of Sep 7 – Sep 13, 2022. Each investigator has a profile showing what they cite most.
When was KDC/ONE SOCAL LABORATORIES, LLC inspected by FDA?
The inspection ran Sep 7 – Sep 13, 2022, and the Form 483 is dated September 13, 2022.
How do I get the full Form 483 for KDC/ONE SOCAL LABORATORIES, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.